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Mucociliary Clearance Completed with Results

Clearing Lungs With ENAC Inhibition in Cystic Fibrosis (CLEAN-CF) (Parion PS-G201)

This study evaluated the drug P-1037 and its effectiveness in combination with the drug hypertonic saline in people with CF. There was no restriction based on CFTR mutation.

 Participants were randomized to receive one of four treatments once daily: 1) P-1037 solution for inhalation (85µg) in hypertonic saline (4.2% saline), 2) P-1037 solution for inhalation (85µg) in saline (0.17% saline), 3) placebo (0.17% saline), or 4) hypertonic saline (4.2% saline).

Eligibility

  • Age:

    12 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 90%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Results

  • What We Learned:

    This study found that P-1037 was safe and generally well-tolerated. However, P-1037 did not have a significant impact on lung function (FEV1) or patient-reported respiratory symptoms (CFQ-R).

  • Primary Findings:

    Effectiveness:

    Safety:

    Out of 142 people dosed, 136 people completed the study. The primary objective of the study was safety. The study met its primary safety endpoint as safety data from the study showed that P-1037 was generally well-tolerated. Secondary objectives evaluated lung function, as measured by FEV1, and patient-reported respiratory symptoms as reported in the CF Questionnaire-Revised (CFQ-R). There were no significant changes in FEV1 or CFQ-R for those who received P-1037.

     

    These results have been provided from a Vertex Press Release and have not been peer reviewed.

     

    P-1037 was acquired by Vertex and development continued in the VX-371-101 study. 

  • Citation:

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    5 weeks

  • Number of Study Visits:

    4

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Parion

  • Study Drugs:

    N/A

Eligibility

  • Age:

    12 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 90%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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